Clinical Observation of Modified Zhizhutang in Treatment of Senile Primary Constipation Due to Qi-Yin Deficiency / 中国实验方剂学杂志

ABSTRACT

Objective:To explore the clinical efficacy of modified Zhizhutang in treating senile primary constipation due to Qi-Yin deficiency and its influences on gastrointestinal neurotransmitters and gastrointestinal motility. Method:One hundred and twenty-one eligible patients were randomly divided into a control group （<italic>n</italic>=60） and an observation group （<italic>n</italic>=61）. On the basis of lifestyle adjustments， patients in the control group further received oral Qihuang Tongmi soft capsule，three capsules per time，three times per day， whereas those in the observation group were further treated with modified Zhizhutang，one bag per day， for eight successive weeks. The number of complete spontaneous bowel movements （CSBM， normal defecation was considered if CSBM ≥ three times per week） before and after treatment was recorded. The main symptoms of constipation，the patient assessment of constipation quality of life （PAC-QOL）， and the traditional Chinese medicine （TCM） syndrome before and after treatment were scored， followed by the anorectal pressure measurement and colonic transit test before and after treatment. The levels of somatostatin （SS），motilin （MTL），substance P （SP） and vasoactive intestinal peptide （VIP） before and after treatment were detected. Result:The weekly average number of CSBM in the observation group was greater than that of the control group （<italic>P</italic><0.01）， but the TCM syndrome score was lower than that of the control group （<italic>P</italic><0.01）. The normal defecation rate in the observation group was 57.38% （35/61），which was higher than 35% （21/60） of the control group （<italic>χ</italic>²=6.092，<italic>P</italic><0.05）. The scores of the main symptoms of constipation in the observation group were significantly lower than those in the control group （<italic>P</italic><0.01）. The PAC-QOL subscale scores and the total score of the observation group significantly declined as compared with those of the control group （<italic>P</italic><0.01）. The anal resting pressure and anal maximum systolic pressure of the observation group were higher than those of the control group （<italic>P</italic><0.01），while the first sensation volume， urge sensation volume and maximum tolerable volume were lower （<italic>P</italic><0.01）. The excretion rates of markers in the observation group at 24 h，48 h and 72 h were significantly elevated in comparison with those in the control group （<italic>P</italic><0.01）. Compared with the control group， the observation group also exhibited increased serum MTL and SP （<italic>P</italic><0.01） and decreased SS and VIP （<italic>P</italic><0.01）. The recurrence rate in the observation group was 34.29% （12/35），obviously lower than 61.90% （13/21） in the control group （<italic>χ</italic>²=5.051，<italic>P</italic><0.05）. The total effective rates in the observation group and the control group were 95.08% （58/61） and 81.67% （49/60） ， implying a significant difference （<italic>χ</italic>²=5.321，<italic>P</italic><0.01）. Conclusion:For the elderly with primary constipation due to Qi-Yin deficiency， oral administration of modified Zhizhutang helps to regulate gastrointestinal neurotransmitters，improve gastrointestinal motility and gastrointestinal emptying rate， alleviate the symptoms of constipation， restore spontaneous bowel movements， improve their quality of life， and lower the recurrence rate. Its clinical effects were better than those of Qihuang Tongmi soft capsule.